Recruiting NCT06424327
A Registry for People With Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient-Reported Outcomes Measurement Information System.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Lung Cancer Stage I. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pulmonary Segmentectomy for Lung Cancer: A Real-World International Registry-TSOG 108
Overview
Participants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.
Interventions
- Other Patient-Reported Outcomes Measurement Information System
Participants-reported outcomes will be collected using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS is a web-based platform developed by the National Institutes of Health. Scoring is standardized on a scale from 0 to 100, with a population mean of 50 and standard deviation of 10 units. High scores mean more of the concept being measured. This study will use PROMIS surveys assessing three domains: physical function (PROMIS bank version 2.0), pain interference (PRO
Primary outcome measures
- Determine 3-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer. [Time frame: 3 years]
- Determine 5-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer. [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Patients suitable for segmentectomy, according to the treating surgeon
- Clinical Stage I with suspected NSCLC, classified preoperatively based on the AJCC TNM staging manual, 9th edition o Note: Tissue diagnosis of NSCLC is not required before enrollment. A pathologic diagnosis of NSCLC may be confirmed preoperatively with biopsy, intraoperatively with frozen section, or postoperatively on final pathology
Exclusion criteria
- Actively receiving lung cancer treatment or a history of lung cancer in the previous 5 years
- History of chemotherapy or radiation therapy for a previous lung cancer
- Synchronous secondary cancer in the lung or elsewhere in the body at the time of surgery
- Carcinoid tumors
- History of other malignancies within the past 3 years, with the exception of non-melanoma skin cancer, superficial bladder cancer, and carcinoma in situ of the cervix
- Actively receiving treatment for other malignancies
- Cases of lobectomy in conjunction with segmentectomy from another lobe and ≥2 segmentectomies from different lobes either en bloc or separate will be excluded from the primary analysis.
- Multi-segmental resection from the same lobe is not a criterion for exclusion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 16 centers
- University of Arizona (Data Collection Only) — Tucson
- University of California San Diego (Data collection) — San Diego
- Rush University Medical Center (Data collection only) — Chicago
- Endeavor Health — Evanston
- University of Michigan (Data Collection Only) — Ann Arbor
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
- … and 8 more centers
Canada · 2 centers
- University Health Network (Data Collection Only) — Toronto
- Centre Hospitalier de l'Université de Montreal (Data Collection Only) — Montreal
Identifiers
NCT: NCT06424327 · 24-127